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Pharmaceutical: Case Studies
- FDA Warning Letter Response and Remediation
A mid-sized company received a ten-item FDA 483. They responded, but subsequently received an FDA warning letter. read more
- Gap Assessment Electronic Records
While preparing for an upcoming FDA audit, a pharmaceutical-grade bulk chemical manufacturer required a gap analysis to determine compliance of quality and laboratory software with requirements for electronic records. read more
- Risk Management in Product Development and Manufacturing
A global manufacturer of pharmaceutical and medical devices needed to better integrate risk management throughout the product lifecycle. read more
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